Peripheral nerve stimulation for RLS or PLMD with sensors for monitoring of sleep-related data

Abstract

A system for monitoring or treating RLS or PLMD can include or use a leg-wearable electrostimulation device for acquiring auxiliary data from a subject at a first leg location at which the device is worn, the first leg-wearable electrostimulation device including or using a first neurostimulation delivery device, an impedance sensor configured for determining an impedance via the first and second skin electrodes, and an auxiliary sensor configured for detecting the auxiliary data of the first leg location at which the device is worn.

What is claimed is: 
     
       1. A system for monitoring or treating at least one of Restless Leg Syndrome (RLS) or Periodic Limb Movement Disorder (PLMD), the system comprising:
 a first leg-wearable electrostimulation device for continuously or intermittently acquiring auxiliary data from a subject at a first leg location at which the device is worn, the first leg-wearable electrostimulation device comprising:
 a first neurostimulation delivery device, configured for delivering transcutaneous neurostimulation therapy to a leg of the subject to treat at least one of RLS or PLMD via first and second skin electrodes at the first leg location; and 
 at least one auxiliary sensor, including at least one of a blood oxygenation sensor, a pulse oximeter, an optical heart sensor, a photoplethysmography (PPG) sensor, an audio physiological sensor, an audio environment sensor, a temperature sensor, a heat flux sensor, a bedmate movement sensor, an environment luminosity sensor, or a circadian/pattern detector, the at least one auxiliary sensor configured for detecting the auxiliary data other than electrode-tissue interface impedance at the first leg location at which the device is worn; 
 
 wherein the first neurostimulation delivery device is configured to receive a response, based at least in part on the auxiliary data, to establish or adjust at least one electrostimulation waveform parameter for delivery at the first leg location; and 
 wherein the at least one auxiliary sensor is configured for detecting a sleep quality indicator or an RLS or PLMD therapy efficacy indicator following the response to establish or adjust the at least one electrostimulation waveform parameter. 
 
     
     
       2. The system of  claim 1 , wherein the at least one auxiliary sensor includes at least one of a position, orientation, or movement sensor configured for detecting at least one of position, orientation, or movement auxiliary data from the leg location at which the device is worn. 
     
     
       3. The system of  claim 1 , wherein the at least one auxiliary sensor includes a blood oxygenation auxiliary sensor configured for detecting blood oxygenation auxiliary data from the leg location at which the device is worn. 
     
     
       4. The system of  claim 3 , wherein the blood oxygenation auxiliary sensor includes a pulse oximeter for detecting blood oxygenation saturation (Sp02) auxiliary data from the leg location at which the device is worn. 
     
     
       5. The system of  claim 1 , wherein the at least one auxiliary sensor includes a heart signal sensor configured for detecting heart signal auxiliary data from the leg location at which the device is worn. 
     
     
       6. The system of  claim 5 , wherein the heart signal sensor includes an optical sensor. 
     
     
       7. The system of  claim 5 , wherein the heart signal sensor includes a photoplethysmography (PPG) sensor. 
     
     
       8. The system of  claim 1 , further comprising processor componentry included in or communicatively coupled to the first leg-wearable electrostimulation device, the processor configured to perform encoded instructions to at least one of monitor, analyze, or diagnose auxiliary data collected from the first leg-wearable electrostimulation device over a period of time. 
     
     
       9. The system of  claim 8 , wherein the processor is configured to, based at least in part on the auxiliary data, perform encoded instructions to provide the response including at least one of:
 generating an alert; 
 monitoring at least one of a severity, progression, or response to electrostimulation treatment; 
 determining or adjusting at least one parameter of a recommended or actual electrostimulation treatment protocol; 
 characterizing at least one of a sleep parameter or a sleep disorder parameter; 
 recommending, programming, or titrating drug delivery via a device-assisted drug delivery protocol; or 
 recommending, programming or titrating at least one of CPAP, neurostimulation, oral sleep appliance via a device-assisted therapy protocol. 
 
     
     
       10. The system of  claim 9 , wherein the at least one of the sleep parameter or the sleep disorder parameter corresponds to at least one of obstructive sleep apnea (OSA), central sleep apnea (CSA), REM sleep behavior disorder, narcolepsy, circadian rhythm sleep disorder, circadian misalignment, jet lag, sleepwalking, insomnia, or parasomnia. 
     
     
       11. The system of  claim 1 , further comprising a second leg-wearable electrostimulation device for continuously or intermittently acquiring auxiliary data from a subject at a second leg location at which the second leg-wearable electrostimulation device is worn on a different leg from the first leg-wearable electrostimulation device, the second leg-wearable electrostimulation device comprising:
 a second neurostimulation delivery device, configured for delivering transcutaneous neurostimulation therapy to the different leg of the subject to treat at least one RLS or PLMD; and 
 a second auxiliary sensor, configured for detecting auxiliary data other than electrode-tissue interface impedance at the second leg location at which the second leg-wearable electrostimulation device is worn. 
 
     
     
       12. The system of  claim 1 , wherein the at least one auxiliary sensor comprises at least one of:
 a body temperature sensor; 
 a body posture or position sensor; 
 a peripheral circulatory function sensor; 
 a heat-flux sensor, configured for at least one of monitoring, detecting, or analyzing at least one of vasodilation or vasoconstriction; or 
 an audio sensor, configured for at least one of monitoring, detecting, or analyzing an indication of pulmonary function, blood pressure, or presence or detected movement of a bedmate. 
 
     
     
       13. The system of  claim 1 , further comprising a docking station or other local interface device communicatively coupled with at least the first leg-wearable electrostimulation device, the local interface device comprising at least one environment sensor for collecting environment data of a sleep environment of the subject. 
     
     
       14. The system of  claim 13 , wherein the environment data includes at least one of luminosity, temperature, audio, or motion of a bedmate or other movement in the sleep environment of the subject. 
     
     
       15. The system of  claim 1 , wherein the at least one auxiliary sensor includes at least one of a pulse oximeter, an optical heart sensor, a photoplethysmography (PPG) sensor, or an audio physiological sensor. 
     
     
       16. A system for monitoring or treating at least one of Restless Leg Syndrome (RLS) or Periodic Limb Movement Disorder (PLMD), the system comprising:
 a first leg-wearable electrostimulation device for continuously or intermittently acquiring auxiliary data from a subject at a first leg location at which the device is worn, the first leg-wearable electrostimulation device comprising:
 a first neurostimulation delivery device, configured for delivering transcutaneous neurostimulation therapy to a leg of the subject to treat at least one of RLS or PLMD via first and second skin electrodes at the first leg location; and 
 a first auxiliary sensor, configured for detecting the auxiliary data other than electrode-tissue interface impedance at the first leg location at which the device is worn for providing a response based at least in part on the auxiliary data; 
 
 a second leg-wearable electrostimulation device for continuously or intermittently acquiring auxiliary data from a subject at a second leg location at which the second leg-wearable electrostimulation device is worn on a different leg from the first leg-wearable electrostimulation device, the second leg-wearable electrostimulation device comprising:
 a second neurostimulation delivery device, configured for delivering transcutaneous neurostimulation therapy to the different leg of the subject to treat at least one RLS or PLMD; and 
 a second auxiliary sensor, configured for detecting auxiliary data other than electrode-tissue interface impedance at the second leg location at which the second leg-wearable electrostimulation device is worn; and 
 
 processor componentry configured for temporally aligning auxiliary data received from the first and second auxiliary sensors for providing temporally-aligned bilateral auxiliary data. 
 
     
     
       17. A system for monitoring or treating at least one of RLS or PLMD of a subject in a sleep environment, the system comprising:
 first and second leg-wearable electrostimulation devices for continuously or intermittently acquiring auxiliary data other than electrode-tissue interface impedance from a subject at respective first and second leg locations at which the device is worn bilaterally on opposing legs, wherein each of the first and second leg-wearable electrostimulation devices comprises: 
 a neurostimulation delivery device, configured for delivering transcutaneous neurostimulation therapy to a leg of the subject to treat at least one of RLS or PLMD via first and second skin electrodes at each of the first and second leg locations; and 
 at least one auxiliary sensor, including at least one of a blood oxygenation sensor, a pulse oximeter, an optical heart sensor, a photoplethysmography (PPG) sensor, an audio physiological sensor, an audio environment sensor, a temperature sensor, a heat flux sensor, a bedmate movement sensor, an environment luminosity sensor, or a circadian/pattern detector, the at least one auxiliary sensor configured for bilaterally detecting the auxiliary data from the respective first and second leg locations at which the first and second leg-wearable electrostimulation devices are worn 
 wherein the neurostimulation delivery device is configured to receive a response, based at least in part on the auxiliary data, to establish or adjust at least one electrostimulation waveform parameter for delivery to at least one of the first and second leg locations; and 
 wherein the at least one auxiliary sensor is configured for detecting a sleep quality indicator or an RLS or PLMD therapy efficacy indicator following the response to establish or adjust the at least one electrostimulation waveform parameter. 
 
     
     
       18. The system of  claim 17 , further comprising a local interface device communicatively coupled with the first and second leg-wearable electrostimulation devices, the local interface device comprising at least one environment sensor for collecting environment data of the sleep environment. 
     
     
       19. A device-assisted method for monitoring or treating a subject receiving transcutaneous neurostimulation therapy in a sleep environment, the method comprising:
 collecting auxiliary data other than electrode-tissue interface impedance, the collecting including using one or more auxiliary sensors respectively located at one or more leg-wearable electrostimulation devices, including collecting at least one of blood oxygenation, pulse oximetry, optical heart sensor, photoplethysmography (PPG), audio physiology, audio environment, temperature, heat flux, bedmate movement, environment luminosity, or circadian/pattern data; 
 generating a response to the auxiliary data, including establishing or adjusting at least one electrostimulation waveform parameter for delivery to an external leg location at which the electrostimulation device is worn; and 
 detecting at least one RLS or PLMD therapy efficacy indicator, via the one or more auxiliary sensors, following the establishing or adjusting the at least one electrostimulation waveform parameter. 
 
     
     
       20. The method of  claim 19 , wherein generating the response to the auxiliary data includes at least one of:
 generating an alert; 
 monitoring at least one of a severity, progression, or response to electrostimulation treatment; 
 determining or adjusting at least one parameter of a recommended or actual electrostimulation treatment protocol; 
 characterizing at least one of a sleep parameter or a sleep disorder parameter; or 
 recommending, programming, or titrating drug delivery via a device-assisted drug delivery protocol; or recommending, programming or titrating at least one of CPAP, neurostimulation, oral sleep appliance via a device-assisted therapy protocol. 
 
     
     
       21. The method of  claim 19 , wherein generating the response to the auxiliary data is also based at least in part on collected environment data about a sleep environment of the subject.